Hemodynamic Support for High-Risk PCI a Key Focus of TCT 2015

October 15, 2015

Use of Hemodynamic Support for High Risk PCI was clearly a major focus at TCT 2015 with multiple didactic sessions and multiple taped and live cases demonstrating its safe and effective use

What I learned (or at least had reinforced)

  1. Many of our patients with advanced CAD and CHF are not being treated and are suffering with angina and dyspnea and have poor health status, depressed left ventricular function, frequent hospitalizations and have poor QOL..
  2. Rethinking the approach with CHIP PCI was recommended. It is often taught to stop after a complicated 1st lesion in multivessel PCI but with the stability of Impella® hemodynamic support it allows complete revascularization in some patients. The interventionalist’s approach of getting in and out has been thought by many as the safest way to treat high risk patients but this has a lot of limitations
    • Incomplete revascularization increases intermediate term risk including MI, death and repeat hospitalization
    • Staged PCI is suboptimal to complete revascularization
    • Leaving “well collateralized” vessels is being recognized as adequate only to maintain myocardial viability but frequently does not limit ischemia and angina
    • Creatinine elevations and concerns about contrast induced nephropathy (CIN) can be reduced by avoiding ad hoc PCI, optimizing hemodynamics prior to PCI, and using a CIN calculator
    • CHIP patients with calcific coronary disease often benefit by use of rotational atherectomy and avoiding atherectomy because of concern about hemodynamic compromise can limit procedural success (“roto-regret”) and may have implications for the durability of PCI results
  3. Many analogies about the hazards of not implementing a Protected PCI strategy were discussed. Dr. Navin Kapur analogized that the complex skill and intellectual requirements placed on the operator during PCI can be like playing chess with hemodynamic support, but without support is more like the added stress and complexity of playing “speed chess” which adds risk to the patient.
  4. “You just never know” when a case planned without support might unravel with complications. A live case highlighted this in a nonagenarian with a calcific LAD lesion that required long and multiple rotablator runs and deep seating of the guide to accomplish, even though brief small burr treatment was the original plan.
  5. As the Impella Technology has evolved on an institutional basis more support is used both in the cases chosen for support but also the level of support;. Some operators risk stratify device use by preprocedure LVEDP or PWP. For these operators LVEDP> 20 mmHg leads to a preference for more support.
  6. Public reporting is a significant overhang on decision making for CHIP (in US not in Europe) The strategy of risk avoidance (not doing the case) deprives the patient of useful therapy and was called an “error of omission” by some speakers. Doing these cases with support adds safety and therefore improves outcomes for both patients (most importantly) and for physician/hospital reporting.
  7. The “heart team evaluation” is many times perfunctory – Most of these CHIP cases are not a competition with our surgical colleagues. CABG operators are delighted to have these high risk patients done with interventional PCI rather than take on the operative risk
  8. Ehtisham Mahmud said that alternative more readily available therapies like IABP “do not increase CO, may get minimal unloading and will increase coronary perfusion but will not give support of cardiac output.” Using IABP as a Protected PCI strategy is “treating yourself” but patients need more support.
  9. CHIP cases often include CTO lesions which require an expanded skill set. Opportunities for learning the basic skills in a didactic setting are increasingly available and sponsored by the three DES manufacturers with opportunities for case proctoring. There is a great value in physicians learning more about this “sub-sub” specialty of interventional cardiology at least to know what opportunities exist as treatment options for our patients. Referral for revascularization to a skilled center with CTO expertise is recommended for patients with advanced symptoms.
  10. Use of Impella hemodynamic support has distinguished many centers for CHIP and CTO work and become large referral bases
  11. THE MOST COMPELLING PATIENT POPULATION: As I have tried to distill the messages presented at TCT 2015 regarding Protected PCI CHIP cases and tried to consider which patient subset might be the most compelling for adoption, I am convinced that the increasing number of post CABG patients in need of revascularization have the greatest need for this technology. These patients and the patients that are surgically ineligible (“turn-downs”) are the easiest to enthusiastically adopt for Protected PCI. Reducing procedural hazard is particularly important because there is little margin for safety and there is:
    • No or exceedingly high risk for morbidity and mortality for surgical bail out if the patient becomes compromised during PCI
    • Surgical bailout is high risk because of pre-procedure DAPT use and associated bleeding

I hope this summary of the topic extensively covered at TCT 2015 was useful. Feel free to contact me with questions, comments, criticisms or concerns.


About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies.  Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi